The Who, What, When, Where and Why of Serious Adverse Event Reporting

What responsibility do healthcare providers have in reporting adverse events?

By Lise Alschuler, ND, FABNO

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One of the key aspects of dietary supplement regulations is the opportunity for consumers, healthcare providers and manufacturers to report serious adverse events. In 2006, President George W. Bush signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The requirements of this act became effective in December 2007. The intention of this act is to provide a way to identify potentially harmful supplements and prevent harm to future consumers. The vision is for adverse event reporting to be a cornerstone in the safe use of dietary supplements.

The 5 Ws of Adverse Events

Who is responsible for reporting serious adverse events (SAEs)? Manufacturers are under mandatory requirements to report serious adverse events related to their products to the US Food and Drug Administration (FDA). Reporting of a serious adverse event is voluntary for healthcare professionals, consumers, and patients. Despite the voluntary nature of SAE reporting, healthcare providers bear significant public health responsibility to report SAEs. In fact, the FDA counsels patients to involve their healthcare provider in reporting a SAE since healthcare providers have the most comprehensive view of the circumstances surrounding the event. Given the nature of the information required, the doctor is the ideal reporter of the SAE.

Despite the voluntary nature of SAE reporting, healthcare providers bear significant public health responsibility to report serious adverse events.

What is an adverse event and what is an SAE with regard to dietary supplements? An adverse event is any incident in which the use of a dietary supplement is suspected to have resulted in an adverse outcome in a patient. Adverse events should be reported to the manufacturer of the product to allow them to investigate the issue. A serious adverse event, on the other hand, is an adverse event with the following outcomes: death, life-threatening condition, hospitalization, disability or permanent damage, or congenital anomaly/birth defect, or an event that requires a medical or surgical intervention to prevent death or disability. Serious adverse events require reporting to the FDA.

Where are SAEs reported? The FDA maintains the SEA reporting program, MedWatch, on its website. The reporting form for providers, consumers, and patients is called the MedWatch 3500 form. This form can be downloaded or completed online. The MedWatch 3500 form requires the following categories of information:

  • Patient information: patient identifier, date of birth or age, sex, and weight
  • Adverse Event: description of the adverse event, the suspected product, date of the event, relevant tests and laboratory data, other relevant history, and preexisting medical conditions (no patient-identifying information is reported)
  • Product Information: availability of the product, name, strength, manufacturer, dose, frequency and route of administration, dates of use, reason for use

Manufacturers must report serious adverse events on the MedWatch 3500A form. Manufacturers must provide patient information, adverse event information, information about the product, and manufacturer contact information.

When is it advisable to report an SAE? If an SAE is suspected to be the result of a product, it should be reported to the FDA as soon as possible. SAE reports can be submitted by the consumer or healthcare professional within 1 year of the event, although within 15 days is encouraged. If the SAE is reported directly to the manufacturer, the FDA requires the manufacturer’s report to be submitted within 15 days of the event.

Why is it important to report an SAE? This allows the FDA to monitor the overall safety of the products and ingredients and to enforce public safety measures when necessary. If, for instance, there is an adulterated ingredient that can cause serious bodily injury in the marketplace, the best chances of detecting the issue are through SAE reporting. Multiple reports related to products with this ingredient in common could identify the ingredient as the source of the problem and allow for appropriate safety measures to be taken. SAE reporting also reinforces the dietary supplement industry’s responsibility toward creating safe and effective products.

Your Role in Patient Safety

When an event occurs that is an adverse event but not an SAE, it is important for the healthcare professional or consumer to report it to the manufacturer. Under the dietary supplement regulations, manufacturers are required to review all product complaints to determine if the product complaint involves failure of the product to meet its specifications. This investigation may lead the manufacturer to test other products and may, if deemed necessary, result in a voluntary product recall to prevent additional harm. Manufacturers cannot do their due diligence on this unless they receive this information from the consumers of their products.

About the Author

Lise Alschuler, ND, FABNO, is a professor of clinical medicine at the University of Arizona where she is the associate director of the Fellowship in Integrative Medicine at the Andrew Weil Center for Integrative Medicine. Alschuler obtained her naturopathic medical degree from Bastyr University where she completed her residency in general naturopathic medicine. She received her bachelor of science degree from Brown University. She is board-certified in naturopathic oncology. Alschuler is past-president of the American Association of Naturopathic Physicians and a founding board member, immediate past-president and current board member of the Oncology Association of Naturopathic Physicians. She is coauthor of Definitive Guide to Cancer, now in its 3rd edition, and Definitive Guide to Thriving After Cancer.